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临床试验/NCT00005613
NCT00005613已完成2 期

A Prospective, Comparative Trial of Allogeneic Versus Autologous Stem Cell Transplantation for High Risk Lymphoma

H. Lee Moffitt Cancer Center and Research Institute2 个研究点 分布在 1 个国家目标入组 147 人开始时间: 1996年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
147
试验地点
2
主要终点
relapse rate

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to compare the effectiveness of allogeneic stem cell transplantation with that of autologous peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma or Hodgkin's disease.

详细描述

OBJECTIVES: I. Compare the relapse rate, progression free survival, and overall survival in patients with high risk non-Hodgkin's lymphoma or Hodgkin's disease treated with allogeneic vs autologous stem cell transplantation. II. Compare the toxicities (short and long term) of these 2 regimens in these patients.

OUTLINE: Cytoreductive therapy: Patients receive 3 courses of salvage chemotherapy (e.g., dexamethasone, high dose cytarabine, and cisplatin (DHAP); etoposide, methylprednisolone, high dose cytarabine, and cisplatin (ESHAP); fludarabine, mitoxantrone, and dexamethasone (FND)). Harvest: Patients with an HLA identical sibling donor are assigned to the allogeneic peripheral blood stem cell (PBSC) transplantation group. Patients without an HLA identical sibling are assigned to the autologous PBSC transplantation group. Allogeneic OR autologous PBSC are harvested. Conditioning regimen: Patients receive high dose chemotherapy comprised of cyclophosphamide IV over 1 hour on days -6 to -3 and carmustine IV over 3 hours and etoposide IV over 3 hours on days -6 to -4. PBSC are infused on day 0. Patients are followed weekly for 3 months, then monthly for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study over 4 years.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Autologous Transplant

Experimental

autologous hematopoietic progenitor cell transplant

干预措施: cyclophosphamide (Drug)

Autologous Transplant

Experimental

autologous hematopoietic progenitor cell transplant

干预措施: etoposide (Drug)

Autologous Transplant

Experimental

autologous hematopoietic progenitor cell transplant

干预措施: BCNU (Drug)

Allogeneic Transplant

Experimental

allogeneic hematopoietic progenitor cell trasnplant

干预措施: cyclophosphamide (Drug)

Allogeneic Transplant

Experimental

allogeneic hematopoietic progenitor cell trasnplant

干预措施: etoposide (Drug)

Allogeneic Transplant

Experimental

allogeneic hematopoietic progenitor cell trasnplant

干预措施: BCNU (Drug)

结局指标

主要结局

relapse rate

时间窗: 5 years

determine relapse rate after allogeneic versus autologous hematopoietic progenitor cell transplantation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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